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5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis

Primary Purpose

Lateral Epicondylitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
%5 dextrose prolotherapy
%15 dextrose prolotherapy
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring lateral epicondylitis, dextrose prolotherapy, pain, injection

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pain score ≥3 according to VAS for more than 3 months in the lateral elbow joint
  • tenderness on palpation over the lateral epicondyle
  • Positiveness in at least two of the tests specific to lateral epicondylitis(LE) (Mills test, resistant middle finger extension and cozen test),
  • > 20 years old , < 60 years old

Exclusion Criteria:

  • Patients who received physical therapy modalities and/or steroid injections in the last 3 months,
  • Having a history of malignancy,
  • Pregnant cases,
  • Those who have bone and joint diseases in the neck, shoulder and elbow,
  • Patients with infection in the treatment area,
  • Patients with arrhythmia or pacemaker in the heart,
  • Patients receiving coagulation disorder or anticoagulant therapy,
  • Those with local dermatological problems,
  • Patients with a history of surgery in the elbow joint,
  • Having a tendon tear
  • Presence of nerve involvement
  • Lack of cooperation and refusal to participate in the study due to cognitive dysfunction

Sites / Locations

  • İstanbul physical medicine rehabilitation training &research hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

%5 dextrose prolotherapy

%15 dextrose prolotherapy

Arm Description

A total of 3 sessions of prolotherapy solution containing 5% dextrose will be applied at the beginning, 3rd week, and the 6th week.

A total of 3 sessions of prolotherapy solution containing 15% dextrose will be applied at the beginning, 3rd week, and the 6th week.

Outcomes

Primary Outcome Measures

The upper extremity disability level
The upper extremity disability level will be evaluated by using the Quick Disabilities of Arm, Shoulder and Hand (QDASH) scale. The maximum score is 100 points. A higher score indicates a worse disability level.
Pain intensity
Pain intensity will be evaluated by using a visual analog scale (VAS). The maximum score is 10 points. A higher score indicates a worse pain level.

Secondary Outcome Measures

Hand grip strength
The standard evaluation tool (a hand dynamometer) will used for measuring grip and squeeze strength minimum value 0 and there is not maximum value, bigger values mean better outcome

Full Information

First Posted
September 20, 2021
Last Updated
February 28, 2022
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05066451
Brief Title
5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis
Official Title
Demonstration and Comparison of 5% Dextrose Prolotherapy and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the treatment of lateral epicondylitis, 5% dextrose prolotherapy is aimed to be more reliable than 15% prolotherapy in terms of side effects and to show that it is similar in terms of efficacy in treatment.
Detailed Description
For this prospective randomized controlled study, volunteer patients who met the inclusion criteria and applied to the Health Sciences University, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital, Physical Medicine and Rehabilitation Outpatient Clinic will be included in the study. Participants who volunteered for the study will be divided into study groups and control groups by stratified randomization. A total of 26 volunteers will be recruited. A solution to be used for prolotherapy is containing 30% dextrose, 2% lidocaine, and physiological saline. In the beginning, all patients were asked about gender, age, body mass index, education level, occupation, duration of complaint, dominant side and affected extremity, previous treatments, and when the last treatment was applied. Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week. Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact. Patients in the control group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose, initially (0.) Week 3 and Week 6. The injection will be made with the same method as the study group. Measurements; will be evaluated at baseline (week 0), immediately after treatment at Week 3, Week 6, and Week 12. Patients; In the evaluation of the visual analog scale (VAS), quick Disabilities of the Arm, Shoulder and Hand (QDASH), Grip strength, hand dynamometer measurements, and adverse events during the study period will be noted.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
lateral epicondylitis, dextrose prolotherapy, pain, injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
%5 dextrose prolotherapy
Arm Type
Experimental
Arm Description
A total of 3 sessions of prolotherapy solution containing 5% dextrose will be applied at the beginning, 3rd week, and the 6th week.
Arm Title
%15 dextrose prolotherapy
Arm Type
Active Comparator
Arm Description
A total of 3 sessions of prolotherapy solution containing 15% dextrose will be applied at the beginning, 3rd week, and the 6th week.
Intervention Type
Other
Intervention Name(s)
%5 dextrose prolotherapy
Intervention Description
Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week. Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.
Intervention Type
Other
Intervention Name(s)
%15 dextrose prolotherapy
Intervention Description
Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose at the beginning(0.) 3rd week and 6th week. Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact.
Primary Outcome Measure Information:
Title
The upper extremity disability level
Description
The upper extremity disability level will be evaluated by using the Quick Disabilities of Arm, Shoulder and Hand (QDASH) scale. The maximum score is 100 points. A higher score indicates a worse disability level.
Time Frame
Change from baseline upper extremity disability level at 3, 6, and 12 weeks
Title
Pain intensity
Description
Pain intensity will be evaluated by using a visual analog scale (VAS). The maximum score is 10 points. A higher score indicates a worse pain level.
Time Frame
Change from baseline pain intensity at 3, 6, and 12 weeks
Secondary Outcome Measure Information:
Title
Hand grip strength
Description
The standard evaluation tool (a hand dynamometer) will used for measuring grip and squeeze strength minimum value 0 and there is not maximum value, bigger values mean better outcome
Time Frame
Change from baseline hand grip strength at 3, 6, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pain score ≥3 according to VAS for more than 3 months in the lateral elbow joint tenderness on palpation over the lateral epicondyle Positiveness in at least two of the tests specific to lateral epicondylitis(LE) (Mills test, resistant middle finger extension and cozen test), > 20 years old , < 60 years old Exclusion Criteria: Patients who received physical therapy modalities and/or steroid injections in the last 3 months, Having a history of malignancy, Pregnant cases, Those who have bone and joint diseases in the neck, shoulder and elbow, Patients with infection in the treatment area, Patients with arrhythmia or pacemaker in the heart, Patients receiving coagulation disorder or anticoagulant therapy, Those with local dermatological problems, Patients with a history of surgery in the elbow joint, Having a tendon tear Presence of nerve involvement Lack of cooperation and refusal to participate in the study due to cognitive dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gokhan Taskin, MD
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training and Research Hospita
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma Nur Kesiktas, Prof
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training and Research Hospita
Official's Role
Study Chair
Facility Information:
Facility Name
İstanbul physical medicine rehabilitation training &research hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16518218
Citation
Fornalski S, Gupta R, Lee TQ. Anatomy and biomechanics of the elbow joint. Tech Hand Up Extrem Surg. 2003 Dec;7(4):168-78. doi: 10.1097/00130911-200312000-00008.
Results Reference
background
PubMed Identifier
26114106
Citation
Kahlenberg CA, Knesek M, Terry MA. New Developments in the Use of Biologics and Other Modalities in the Management of Lateral Epicondylitis. Biomed Res Int. 2015;2015:439309. doi: 10.1155/2015/439309. Epub 2015 May 31.
Results Reference
background
PubMed Identifier
20188998
Citation
Rabago D, Slattengren A, Zgierska A. Prolotherapy in primary care practice. Prim Care. 2010 Mar;37(1):65-80. doi: 10.1016/j.pop.2009.09.013.
Results Reference
background
PubMed Identifier
18240327
Citation
Jensen KT, Rabago DP, Best TM, Patterson JJ, Vanderby R Jr. Early inflammatory response of knee ligaments to prolotherapy in a rat model. J Orthop Res. 2008 Jun;26(6):816-23. doi: 10.1002/jor.20600.
Results Reference
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5% and 15% Dextrose Prolotherapy Efficacy in Lateral Epicondylitis

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